Empowered Diagnostics recalls COVID-19 tests: U.S. FDA

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SAN FRANCISCO, Calif. (KRON) – The U.S. Food and Drug Administration is warning people not to use the Empowered Diagnostics COVID-19 tests which are falsely labeled as being authorized by the FDA.

The warning was issued for the CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test.

Empowered Diagnostics recalled the products — The FDA says the issue is a Class I recall, which is the most serious type.

According to the FDA, neither test has been authorized, cleared, or approved by them.

When not using an authorized test, the FDA says there is potential for higher risk of false results.

Empowered Diagnostics says the following people may be affected:

  • People who were tested using these medical devices 
  • Health care providers who may have access to and use these tests or whose patients have used these tests
  • Organizers of large testing programs, such as in the workplace or schools, who may be using and distributing these tests for diagnostic use
  • Distributors

For the full recall statement, visit the U.S. Food and Drug Administration website.

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